Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 21-22 are added, and claims 1 and 5-22 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 12/17/2025.
Response to Arguments
Applicant’s arguments filed 03/13/2026 with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1, 5-6, 11-13, 18-19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Roham et al. (US 20120232398 A1, published September 13, 2012) in view of Z. Alfirevic et al, "Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour (Review)", Cochrane Database of Systematic Reviews, vol. 2, no. 2, pp. 1-109, Feb. 2017, Schmitt et al. (US 20190117199 A1, published April 25, 2019), and Yoo (KR 102375823 B1, published March 17, 2022), hereinafter referred to as Roham, Alfirevic, Schmitt, and Yoo, respectively.
Regarding claim 1, and similarly for claim 18, Roham teaches a maternal and fetal monitoring system (Fig. 1) comprising:
a first ultrasound transducer configured to be positioned on a maternal patient abdomen to acquire fetal ultrasound measurements of a fetus, the first ultrasound transducer housed in a first housing (Fig. 1, central unit 10 as first ultrasound transducer on abdomen 22; see para. 0059 "The device consists of a central unit 10 which houses the fetal heartbeat detector (ultrasound piezoelectric transducer in one implementation of an ultrasound Doppler detector)...");
a maternal measurement patch configured to be secured on the maternal abdomen and to obtain UA physiological measurements indicative of uterine activity (UA) of the maternal patient (Fig. 1, toco transducer 12 as maternal measurement patch on abdomen 22; Fig. 3; see para. 0068 "The maternal uterine contraction actuator, such as a toco pressure sensor 38, provides output corresponding to maternal contractions to amplification and signal conditioning circuit 40..."),
a connection cable connecting the maternal measurement patch to the first housing (Fig. 1, cable connecting toco transducer 12 (maternal measurement patch) to central unit 10 (first housing)) and
configured to transmit the UA physiological measurements from the maternal measurement patch to the housing of the first ultrasound transduce such that the UA physiological measurements are received by a controller (where the controller is housed in the first housing; see para. 0059 "The toco transducer 12 [maternal measurement patch] may be integrated with the sensor or central unit 10, or may be separate and connected to the central unit using a wire [connection cable]."; see para. 0066 "A toco pressure sensor [maternal measurement patch], an optional audio feedback earphone and the optional external Bluetooth necklace can be plugged in to the central unit."; see para. 0065-- "The central unit integrates the ultrasound transducers, processing and control circuitry [controller], and the internal Bluetooth communication module."),
wherein the connection cable is configured to enable placement of the first ultrasound transducer level with or below the umbilicus while the maternal measurement patch is secured on the upper portion of the maternal abdomen (Fig. 1, cable between central unit 10 and toco sensor 12; see para. 0066 "Separate belts are preferably used to hold the central unit [includes ultrasound transducer] and toco sensor [maternal measurement patch] that during operation, position of sensors can be independently optimized." It is known in the art to measure uterine contractions at the upper portion of the abdomen, and measure fetal heart rate below the belly button of the maternal abdomen, so it is inherent to have the connection cable between the maternal measurement patch and fetal ultrasound transducer long enough to measure the uterine contractions and fetal heart rate simultaneously); and
the controller configured to determine fetal heart rate (fHR) values for the fetus based on the fetal ultrasound measurements and to determine UA values for the maternal patient based on the UA physiological measurements (Fig. 3; see para.0068 "The fetal heartbeat detector, such as a piezoelectric ultrasoundtransducer30, is an input to the sensing hardware 32. The output of the sensor 30 is provided to signal processor34, such as Doppler signal processing detector, for processing and heartbeat detection. In turn, the signal digitization unit 36 digitizes the signal, such as through an analog to digital converter (ADC), and may optionally perform heart rate calculation, as well as to provide control and data functions. The maternal uterine contraction actuator, such as a toco pressure sensor 38, provides output corresponding to maternal contractions to amplification and signal conditioning circuit 40, again optionally a utilizing a low noise amplifier (LNA), which in turn is passed to the signal digitization unit36.").
Roham teaches a maternal measurement patch and a first ultrasound transducer placed on the abdomen, and it is inherent and known in the art (external cardiotocography (CTG) monitoring) to place one sensor measuring fetal heart rate at the location of the fetal heart, which is usually below the patient's belly button, and to place another sensor measuring uterine activity at the fundus, which is above the belly button during pregnancy, but Roham does not explicitly teach wherein the maternal measurement patch is configured to be adhered to an upper portion of the maternal abdomen while the first ultrasound transducer level is level with or below the umbilicus.
Whereas, Alfirevic, in the same field of endeavor, teaches wherein the maternal measurement patch is configured to be adhered to an upper portion of the maternal abdomen while the first ultrasound transducer level is level with or below the umbilicus (see pg. 100, Table 1 "The fetal heart rate and the activity of the uterine muscle are detected by two transducers placed on the mother's abdomen (one above the fetal heart and the other at the fundus). Doppler ultrasound provides the information which is recorded on a paper strip known as a cardiotocograph (CTG).").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the maternal measurement patch and the ultrasound transducer, as disclosed in Roham, by having the maternal measurement patch is configured to be adhered to an upper portion of the maternal abdomen while the first ultrasound transducer level is level with or below the umbilicus, as disclosed in Alfirevic. One of ordinary skill in the art would have been motivated to make this modification in order to continuously monitor the baby's heart rate and the mother's uterine contractions during labor, as taught in Alfirevic (see pg. 7, col. 1, para. 5).
Roham in view of Alfirevic teaches a maternal measurement patch secured to the abdomen, but does not explicitly teach wherein the maternal measurement patch includes an adhesive.
Whereas, Schmitt, in the same field of endeavor, teaches wherein the maternal measurement patch includes an adhesive (see para. 0006-" pressure transducer (also called toco transducer, or tocodynamometer) for measuring uterine activity. Each of the transducers may be placed on the abdomen of the mother, e.g. by an elastic belt fitted around the waist or by an adhesive tape or patch.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified securing the maternal measurement patch to the abdomen, as disclosed in Roham in view of Alfirevic, by securing the maternal measurement patch to the abdomen via an adhesive, as disclosed in Schmitt. One of ordinary skill in the art would have been motivated to make this modification in order to allow movement of the mother without interfering with continuous measurement monitoring.
Roham in view of Alfirevic and Schmitt teaches operating the maternal measurement patch to obtain the UA physiological measurements and operating the first ultrasound transducer to obtain the fetal ultrasound measurements, but does not explicitly teach operating one transceiver when another transceiver is not operating.
Whereas, Yoo, in an analogous field of endeavor, teaches wherein the controller is further configured to operate the maternal measurement patch to obtain the UA physiological measurements when the first ultrasound transducer is not operating to acquire the fetal ultrasound measurements (Fig. 3; see pg. 4, para. 4-5 – “In this case, during the first time interval TI1, the ultrasound apparatus 10 drives the first ultrasound array 110 based on the first control signal CS1 to transmit the first ultrasound transmission signal UT1, The first ultrasonic reception signal UR1 reflected from the object may be received. On the other hand, during the first time interval TI1 , the ultrasound apparatus 10 may not be driven by turning off the second ultrasound array 120 based on the second control signal CS2. After the second time T2, the ultrasound apparatus 10 may not be driven by turning off the first ultrasound array 110 based on the first control signal CS1 for the second time interval TI2, On the other hand, the ultrasound apparatus 10 drives the second ultrasound array 120 based on the second control signal CS2 to transmit the second ultrasound transmission signal UT2, and the second ultrasound reception signal reflected from the object ( UR2) can be received.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified operating the maternal measurement patch to obtain the UA physiological measurements and operating the first ultrasound transducer to obtain the fetal ultrasound measurements, as disclosed in Roham in view of Alfirevic and Schmitt, by operating the maternal measurement patch to obtain the UA physiological measurements when the first ultrasound transducer is not operating to acquire the fetal ultrasound measurements, as disclosed in Yoo. One of ordinary skill in the art would have been motivated to make this modification in order to prevent interference between the two signals and improve signal quality.
Furthermore, regarding claim 5, Roham further teaches wherein the connection cable includes a connection end configured to removably connect to a connection port on the first housing (see para. 0066 "A toco pressure sensor [maternal measurement patch], an optional audio feedback earphone and the optional external Bluetooth necklace can be plugged in [removable connect] to the central unit [first housing with ultrasound transducers].").
Furthermore, regarding claims 6 and 19, Roham further teaches wherein the UA physiological measurements indicative of UA of the maternal patient include ultrasound measurements, light transmission measurements, force measurements, electrical potentials, or any combination thereof (Fig. 1; see para. 0059 "..a pressure [force] sensor, such as a toco transducer, for monitoring of contractions.").
Furthermore, regarding claim 11, Roham further teaches wherein the maternal measurement patch includes at least one of a force gauge sensor configured to acquire force measurements indicative of the UA of the maternal patient or a plurality of EMG sensors configured to acquire electrical potentials indicative of the UA of the maternal patient (see para. 0007 "Typically, a conventional tocodynamometer is a strain gauge attached to a belt around the abdomen of the patient. "; see para. 0026 "Contraction is measured either by a pressure sensor, EMG of uterine muscles or manually entered by user.").
Furthermore, regarding claim 12, Roham further teaches wherein the controller is housed in the first housing and further comprising a wireless transmitter in the first housing and configured to transmit at least the UA values and the fHR value to a receiving device (Fig. 1; see para. 0065 "The central unit [10, first housing] integrates the ultrasound transducers, processing and control circuitry, and the internal Bluetooth communication module [wireless transmitter]."; see para.0074 "A transmission between the gateway [20, receiving device] and the central unit [10, first housing] is initiated by the gateway and acknowledged by a 3 byte response from the central unit consisting of the heart rate, contraction information, and an error code at an update rate of 2-10 Hz.").
Furthermore, regarding claim 13, Roham further teaches a wireless transmitter in the first housing and configured to transmit the fetal ultrasound measurements and the UA physiological measurements to an external patient monitor, wherein the controller is in the external patient monitor (Fig. 1; see para. 0065 "The central unit [10, first housing] integrates the ultrasound transducers, processing and control circuitry, and the internal Bluetooth communication module [wireless transmitter]."; see para. 0074-"A transmission between the gateway [20, external patient monitor] and the central unit [10, first housing] is initiated by the gateway and acknowledged by a 3 byte response from the central unit consisting of the heart rate, contraction information, and an error code at an update rate of 2-10 Hz."; see para. 0067 "FIG. 2 is a plan view of a representative gateway device 20. The gateway device may preferably include data visualization. In FIG. 2, the fetal heartbeat is shown in the upper waveform, and the signal corresponding to the maternal contractions are displayed in the lower portion.").
Furthermore, regarding claims 21 and 22, Yoo further teaches wherein the controller is configured to control the first ultrasound transducer such that it is not powered to transmit or receive ultrasound when the maternal measurement patch is operated to obtain the UA physiological measurements (Fig. 3; see pg. 4, para. 4-5 – “In this case, during the first time interval TI1, the ultrasound apparatus 10 drives the first ultrasound array 110 based on the first control signal CS1 to transmit the first ultrasound transmission signal UT1, The first ultrasonic reception signal UR1 reflected from the object may be received. On the other hand, during the first time interval TI1 , the ultrasound apparatus 10 may not be driven by turning off the second ultrasound array 120 based on the second control signal CS2. After the second time T2, the ultrasound apparatus 10 may not be driven by turning off the first ultrasound array 110 based on the first control signal CS1 for the second time interval TI2, On the other hand, the ultrasound apparatus 10 drives the second ultrasound array 120 based on the second control signal CS2 to transmit the second ultrasound transmission signal UT2, and the second ultrasound reception signal reflected from the object ( UR2) can be received.”).
The motivation for claims 21-22 was shown previously in claim 1 and 18.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Roham in view of Alfirevic, Schmitt, and Yoo, as applied to claim 1 above, and in further view of Gaster (US 20160157717 A1, published June 9, 2016), from IDS, hereinafter referred to as Gaster.
Regarding claim 7 Roham in view of Alfirevic, Schmitt, and Yoo teaches all of the elements disclosed in claim 1 above.
Roham in view of Alfirevic, Schmitt, and Yoo teaches a maternal measurement patch, but does not explicitly teach where the maternal measurement patch includes an ultrasound transducer.
Whereas, Gaster, in an analogous field of endeavor, teaches wherein the maternal measurement patch includes a second ultrasound transducer configured to acquire UA ultrasound measurements indicative of the UA of the maternal patient, wherein the controller is configured to determine the UA values based on the UA ultrasound measurements and wherein the second ultrasound transducer emits and measures a different ultrasound frequency than the first ultrasound transducer (see para. 0071 "In alternative embodiments, one or both of the EMG sensor or FHR sensor may be replaced by a Doppler ultrasound sensor 608'. In such embodiments, an FHR signal or EMG signal may include indications of FHR or uterine contractions derived from Doppler analysis of ultrasonic input." It is inherent and known in the art to operate a transducer at a different frequency than another transducer to receive two different physiological signals from the body).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a maternal measurement patch, as disclosed in Roham in view of Alfirevic, Schmitt, and Yoo, by having the maternal measurement patch include an ultrasound transducer, as disclosed in Gaster. One of ordinary skill in the art would have been motivated to make this modification in order to provide diagnostic information regarding health of the fetus, automated non-stress test for the fetus, the onset and progress of labor and delivery, as taught in Gaster (see para. 0039).
Furthermore, regarding claim 8, Gaster further teaches wherein the maternal measurement patch includes a second ultrasound transducer configured to acquire UA ultrasound measurements indicative of the UA of the maternal patient (see para. 0071 "In alternative embodiments, one or both of the EMG sensor or FHR sensor may be replaced by a Doppler ultrasound sensor 608'. In such embodiments, an FHR signal or EMG signal may include indications of FHR or uterine contractions derived from Doppler analysis of ultrasonic input."), and
Yoo further teaches wherein the controller is configured to determine the UA values based on the UA ultrasound measurements and wherein the controller is configured to control operation of the second ultrasound transducer to acquire the UA ultrasound measurements when the first ultrasound transducer is not operating to acquire the fetal ultrasound measurements (Fig. 3; see pg. 4, para. 4-5 – “In this case, during the first time interval TI1, the ultrasound apparatus 10 drives the first ultrasound array 110 based on the first control signal CS1 to transmit the first ultrasound transmission signal UT1, The first ultrasonic reception signal UR1 reflected from the object may be received. On the other hand, during the first time interval TI1 , the ultrasound apparatus 10 may not be driven by turning off the second ultrasound array 120 based on the second control signal CS2. After the second time T2, the ultrasound apparatus 10 may not be driven by turning off the first ultrasound array 110 based on the first control signal CS1 for the second time interval TI2, On the other hand, the ultrasound apparatus 10 drives the second ultrasound array 120 based on the second control signal CS2 to transmit the second ultrasound transmission signal UT2, and the second ultrasound reception signal reflected from the object ( UR2) can be received.”).
The motivation for claim 8 was shown previously in claims 1 and 7.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Roham in view of Alfirevic, Schmitt, and Yoo, as applied to claim1 above, and in further view of Yermoshkin et al. (US 20220071552A1, published March 10, 2022), hereinafter referred to as Yermoshkin.
Regarding claim 9, Roham in view of Alfirevic, Schmitt, and Yoo teaches all of the elements disclosed in claim 1 above.
Roham in view of Alfirevic, Schmitt, and Yoo teaches a maternal measurement patch, but does not explicitly teach where the maternal measurement patch includes a light transmission measurement device.
Whereas, Yermoshkin, in an analogous field of endeavor, teaches wherein the maternal measurement patch includes a light transmission measurement device configured to acquire light transmission measurements indicative of the UA of the maternal patient, wherein the controller is configured to determine the UA values based on the light transmission measurements (Fig. 10-11; see para. 0188- "According to one or more embodiments, the processor may be configured to receive an output signal from the light detector 18 representative of the intensity of the light that is detected by the light detector 18. The processor may detect and monitor variation in the light intensity of the light over time based on the output signal. The processor may determine uterine contractions based on the determined variation of the intensity received by the light detector.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a maternal measurement patch, as disclosed in Roham in view of Alfirevic, Schmitt, and Yoo, by having the maternal measurement patch include a light transmission measurement device, as disclosed in Yermoshkin. One of ordinary skill in the art would have been motivated to make this modification in order for the measurement sensitivity remain constant over a longer displacement range, as disclosed in Yermoshkin (see para. 0080-0082).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Roham in view of Alfirevic, Schmitt, Yoo, and Yermoshkin, as applied to claim 9 above, and in further view of Reuter et al. (US 20150150538 A1, published June 4, 2015), from IDS, hereinafter referred to as Reuter.
Regarding claim 10, Roham in view of Alfirevic, Schmitt, Yoo, and Yermoshkin teaches all of the elements disclosed in claim 9 above.
Roham in view of Alfirevic, Schmitt, Yoo, and Yermoshkin teaches a maternal measurement patch, but does not explicitly teach where the maternal measurement patch acquires light transmission measurement indicative of maternal heart rate to determine a heartbeat coincidence.
Whereas, Reuter, in the same field of endeavor, teaches wherein the maternal measurement patch is further configured to acquire light transmission measurements indicative of maternal heart rate (mHR) values (Fig. 1-2; see para. 0036 "The optical transducer26 is therefore also in contact with the abdomen 14. It uses an optical method to detect a pulsation of dermal blood vessels to derive a maternal heart rate signal MHR1."), and
wherein the controller is further configured to determine a heartbeat coincidence based on the fHR values and the mHR values (see para. 0044 "Moreover, the fetal monitoring system10 comprises a cross-channel verification unit 42 that is provided for determining a cross-channel verification between traces of two of the signals continuously over time. One of the two signals is the maternal heart rate signal MHR1, MHR2, MHR3 derived from anyone of the acceleration sensors 30, 32 and the optical transducer 6. The other one of the two signals is the fetal heart rate FHR taken up by the transducer28 designed as an ultrasonic Doppler sensor.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a maternal measurement patch, as disclosed in Roham in view of Alfirevic, Schmitt, Yoo, and Yermoshkin, by having the maternal measurement patch acquire light transmission measurement indicative of maternal heart rate to determine a heartbeat coincidence, as disclosed in Reuter. One of ordinary skill in the art would have been motivated to make this modification in order to significantly increase reliability and robustness of the fetal monitoring system and the risk of intrapartum fetal mortality is reduced, as taught in Reuter (see para. 0046).
Claim 14-15 and 20 is rejected under 35 U.S.C. 103 as being unpatentable over Roham in view of Alfirevic, Schmitt, and Yoo, as applied to claims 1 and 18 above, respectively, and in further view of Reuter.
Regarding claims 14 and 20, Roham in view of Alfirevic, Schmitt, and Yoo teaches all of the elements disclosed in claim 1 and 18 above, respectively.
Roham in view of Alfirevic, Schmitt, and Yoo teaches a maternal measurement patch, but does not explicitly teach where the maternal measurement patch measures maternal heart rate to determine a heartbeat coincidence.
Whereas, Reuter, in the same field of endeavor, teaches wherein the maternal measurement patch is further configured to acquire measurements indicative of maternal heart rate (mHR)values, and wherein the controller is further configured to determine a heartbeat coincidence based on the fHR values and the mHR values (see para. 0044 "Moreover, the fetal monitoring system 10 comprises a cross channel verification unit 42 that is provided for determining a cross-channel verification between traces of two of the signals continuously over time. One of the two signals is the maternal heart rate signal MHR1, MHR2, MHR3derived from anyone of the acceleration sensors 30, 32 and the optical transducer26.The other one of the two signals is the fetal heart rate FHR taken up by the transducer 28 designed as an ultrasonic Doppler sensor.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a maternal measurement patch, as disclosed in Roham in view of Alfirevic, Schmitt, and Yoo, by having the maternal measurement patch measure maternal heart rate to determine a heartbeat coincidence, as disclosed in Reuter. One of ordinary skill in the art would have been motivated to make this modification in order to significantly increase reliability and robustness of the fetal monitoring system and the risk of intrapartum fetal mortality is reduced, as taught in Reuter (see para. 0046).
Furthermore, regarding claim 15, Reuter further teaches wherein the controller is configured to receive maternal heart rate (mHR) values from a maternal heart rate monitor configured to be worn by the maternal patient and configured to transmit the mHRvalues (see para. 0036 "The first transducer unit 16 comprises a housing 20 that partially encompasses a transducer 24 designed as a tocodynamometer having a flat area that is in contact with the abdomen 14."),
wherein the controller is further configured to determine a heartbeat coincidence based on the fHR values and the mHRvalues (see para. 0044 "Moreover, the fetal monitoring system10 comprises a cross-channel verification unit 42 that is provided for determining a cross-channel verification between traces of two of the signals continuously over time. One of the two signals is the maternal heart rate signal MHR1, MHR2, MHR3 derived from anyone of the acceleration sensors 30, 32 and the optical transducer 26. The other one of the two signals is the fetal heart rate FHR taken up by the transducer28 designed as an ultrasonic Doppler sensor.").
The motivation for claim 15 was shown previously in claim 14.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Roham in view of Alfirevic, Schmitt, Yoo, and Reuter, as applied to claim15 above, and in further view of Lau et al. (US 20180110434 A1, published April 26, 2018), hereinafter referred to as Lau.
Regarding claim 16, Roham in view of Alfirevic, Schmitt, Yoo, and Reuter teaches all of the elements disclosed in claim 15 above.
Roham in view of Alfirevic, Schmitt, Yoo, and Reuter teaches a maternal heart rate monitor, but does not explicitly teach where the maternal heart rate monitor is worn on the maternal patient's wrist.
Whereas, Lau, in an analogous field of endeavor, teaches wherein the maternal heart rate monitor is a wrist-worn heart rate monitor configured to be worn on the maternal patient's wrist (Fig. 1A, wrist band 102 measuring maternal heart rate mechanical pulse signal 101).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a maternal heart rate monitor, as disclosed in Roham in view of Alfirevic, Schmitt, Yoo, and Reuter, by having the maternal heart rate monitor worn on the maternal patient's wrist, as disclosed in Lau. One of ordinary skill in the art would have been motivated to make this modification in order to have no fetal mechanical pulse detectable in the maternal arm or wrist areas to confuse the isolation or extraction of fetal ECG signals, as taught in Lau (see para. 0012).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Roham in view of Alfirevic, Schmitt, and Yoo, as applied to claim 1 above, and in further view of Hayes-Gill et al. (US 20120150010A1, published June 14, 2012), hereinafter referred to as Hayes-Gill.
Regarding claim 17, Roham in view of Alfirevic, Schmitt, and Yoo teaches all of the elements disclosed in claim 1 above, and
Roham further teaches an accelerometer configured to measure motion of the maternal patient (see para. 0080 "Temperature sensors and accelerometers are among other possibilities, e.g., in a wearable, adhesive patch, one or more accelerometers can additionally capture the activity level of the person to help in additional assessment of health and well being.").
Roham in view of Alfirevic, Schmitt, and Yoo teaches an accelerometer configured to measure motion of the maternal patient, but does not explicitly teach using maternal motion data to remove artifact from uterine activity physiological measurements.
Whereas, Hayes-Gill, in an analogous field of endeavor, teaches wherein the controller is further configured to receive maternal motion data from the accelerometer and to use the maternal motion data to remove artifact from at least one of the UA physiological measurements and the fHR values (see para. 0102 "Thus, in a general aspect, the signal processor 97 separates a uterine electromyogram signal from fetal and maternal heart rate signals and then filters or attenuates motion artefacts from the uterine electromyogram signal using the movement signals from a movement sensor 98 [accelerometer]or other movement detector to generate electrohysterogram (EHG) [uterine contraction] data from the uterine electromyogram signal.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified an accelerometer configured to measure motion of the maternal patient, as disclosed in Roham in view of Alfirevic, Schmitt, and Yoo, by using the maternal motion data to remove artifact from uterine activity physiological measurements, as disclosed in Hayes-Gill. One of ordinary skill in the art would have been motivated to make this modification in order to provide a substantial improvement in the accurate and reliable determination of the frequency and duration of contractions, and allow suppression of false positive contractions when the mother is active, as taught in Hayes-Gill (see para. 0102).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ichikawa (US 20090187105 A1, published July 23, 2009) discloses a control portion for causing the first and second ultrasound transducers to perform transmitting and receiving so that periods of transmitting and receiving by the first and second ultrasound transducers do not overlap.
Park et al. (US 20230181934 A1, published June 15, 2023) discloses first and second transducers operating sequentially (alternately), and the waveform and frequency of the first ultrasound transducer may differ from the waveform and frequency of the second transducer.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.C./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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